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Arava 10 mg film-coated tablets

  • Name:

    Arava 10 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Leflunomide

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/03/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 16/10/2019

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 17 March 2020 PIL

Reasons for updating

  • Change in co-marketing arrangement

Free text change information supplied by the pharmaceutical company

Article 61.3 notification to update of the local representatives in Malta 

Updated on 22 October 2019 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 16 October 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 16 October 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 8 October 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 13 December 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section4.4 added:-

Interference with determination of ionised calcium levels

The measurement of ionised calcium levels might show falsely decreased values under treatment with leflunomide and/or teriflunomide (the active metabolite of leflunomide) depending on the type of ionised calcium analyser used (e.g. blood gas analyser). Therefore, the plausibility of observed decreased ionised calcium levels needs to be questioned in patients under treatment with leflunomide or teriflunomide. In case of doubtful measurements, it is recommended to determine the total albumin adjusted serum calcium concentration.

Updated on 11 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 December 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 9 August 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Respiratory reactions

 

Interstitial lung disease, as well as rare cases of pulmonary hypertension have been reported during treatment with leflunomide (see section 4.8).

Updated on 12 February 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 24 November 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2- Formatted text

4.3- Formatted text

4.4- Formatted text and Colitis reported in patients treated with leflunomide

4.5- Formatted text

4.6- Adverse effects on male reproductive organs were observed (animals)

4.8- Colitis added

5.2- Formatted text

6.4- Wording update.

Updated on 3 February 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 7 November 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to further information section
  • Change to date of revision

Updated on 10 October 2014 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type IIC Bulk - CCDS v18 and v19 (WS 560 v62)

Updated on 4 June 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type IB - DRESS Syndrome and PRAC recommendations. The information of local representatives for Finland, Malta, Sweden and UK has also been updated (WS 0526).

Updated on 30 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 24 February 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type IA-IN bulk - Addition of Croatia QRD v9. EMEA/H/C/235/IAin/354/G

Updated on 20 February 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 12 April 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 8 January 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Variation 56 - skin disorders

Updated on 22 September 2011 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update Section 4.2 & 5.1: Information on dosing in rheumatoid & psoriatic arthritis

Updated on 1 June 2011 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 21 March 2011 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 8 May 2008 PIL

Reasons for updating

  • Change to side-effects
  • Improved electronic presentation
  • Joint PIL superseded by PILs for individual presentations

Updated on 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 20 March 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 28 September 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

  • HCP Educational Material, Patient Educational MaterialRisk Minimisation Materials

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